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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER PAYKEL HEALTHCARE LIMITED FISHER PAYKEL HEALTHCARE; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
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FISHER PAYKEL HEALTHCARE LIMITED FISHER PAYKEL HEALTHCARE; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER Back to Search Results
Model Number RT280
Device Problem Fitting Problem (2183)
Patient Problem Insufficient Information (4580)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
When setting up ventilators this afternoon, my coworker and i came across 4 circuits (rt280) that we were unable to use because we could not put the heated wire adaptor in the end of the circuit.The prongs were not bent, yet the adaptor would not fit into them.There were two different lots involved: 2101489277 and 2101552907.Manufacturer response for ventilator circuit, ventilator circuit (per site reporter): (b)(6) notified them on the beginning of august, at which time they sent 10 circuits to replace the 4 defective ones.They said they notified their quality control department.
 
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Brand Name
FISHER PAYKEL HEALTHCARE
Type of Device
HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
Manufacturer (Section D)
FISHER PAYKEL HEALTHCARE LIMITED
173 technology dr
suite 100
irvine CA 92618
MDR Report Key12352768
MDR Text Key267655697
Report Number12352768
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberRT280
Device Catalogue NumberRT280
Device Lot Number2101489277, 2101552907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/13/2021
Event Location Hospital
Date Report to Manufacturer08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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